The company is conducting its trial at its Zydus Research Centre in Moraiya near Ahmedabad.
The Ahmedabad-based company had earlier this month received an approval from the Drug Controller General of India V.G. Somani to conduct a phase I/II trial on 1,048 participants. The entire trial is expected to complete in one year, as per the government’s clinical trial registry.
The 1,048 healthy participants will be divided into two groups, with the first being given the vaccine candidate and the second a placebo. Placebo is a substance with no therapeutic effect that is used only to act as a control arm of the trial against which the vaccine candidate will be compared.
As part of the trial, three doses of the vaccine will be given to the participants, with the first dose on day 0, and the subsequent two doses 28 days apart, as per the clinical trial registry.
Zydus Cadila’s vaccine candidate is one of two from India for which human trials have been allowed. The other candidate is the one jointly developed by Bharat Biotech International Ltd and Indian Council of Research’s National Institute of Virology in Pune.
Unlike Zydus’ vaccine candidate, Bharat Biotech’s vaccine has been under considerable limelight since a controversial letter was written by the ICMR director-general Balram Bhargava earlier this month directing the company and the 12 principal investigators at the trial sites to expedite the trial to start enrolment by 7 July and complete it by 15 August.